Glenmark Pharma gets nod for phase 1 trial of novel molecule

The novel molecule, GRC 54276, is a hematopoietic progenitor kinase 1 (HPK1) inhibitor, which improves antitumor immunity by activating and priming T cells.

Glenmark Pharmaceuticals' subsidiary, Glenmark Specialty S.A., has received approval from the Indian drug regulator, Drug Controller General of India (DCGI), to conduct a phase 1 clinical trial of its novel small-molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor.

HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, which improves antitumor immunity by activating and priming T cells. GRC 54276 has shown tumor cell killing ability in preclinical studies as a single agent and as well in combination with checkpoint inhibitors, making it a high-priority target in immuno-oncology.

Glenmark will initiate a Phase 1 clinical trial by June 2022 to determine the safety, tolerability, and preliminary anti-tumor activity of its novel molecule in patients with advanced solid tumors and Hodgkin's lymphoma.

The company also plans to file an IND in the US and Clinical Trial Applications in Europe to kick-off a fully global clinical study program.

We are delighted that our first novel molecule from the newly formed 'Innovative Medicines Group' within Glenmark has received approval from India's drug regulator to initiate a Phase 1 clinical trial. This reinforces Glenmark's growing capabilities of innovative clinical research and is a step closer in providing holistic solutions for cancer treatment, said Glenn Saldanha, chairman & managing director, Glenmark Pharmaceuticals.

Glenmark Pharmaceuticals is an innovation-driven global pharmaceutical company with a presence across specialty, generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology.

The drug maker's consolidated net profit fell 3.4% to Rs 239.75 crore on 13.9% rise in net sales to Rs 3,141.47 crore in Q3 FY22 over Q3 FY21.

Shares of Glenmark Pharmaceuticals rose 0.68% at Rs 479.20 on Friday.

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